NDC 0517-0761 - Ofloxacin

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0517-0761
Package NDCs from labels
0517-0761-01
Manufacturer
American Regent, Inc. | PharmaForce, Inc.
Effective date
2010-07-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
OFLOXACIN OPHTHALMIC SOLUTION, USP 0.3% (3 mg/mL)American Regent, Inc. | PharmaForce, Inc.2010-07-08HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0517-0761-012019-10-21C16284748780-1956f9ecf-c04e-621f-e053-dbdaa90a74adOFLOXACIN OPHTHALMIC SOLUTION, USP 0.3% (3 mg/mL)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0517-0761-01Ofloxacin10 mL in 1 BOTTLESOLUTION/ DROPS101
0517-0761-01Ofloxacin1 in 1 CARTONSOLUTION/ DROPS11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0517-0761OFLOXACIN SOLUTION/ DROPS [AMERICAN REGENT, INC.]12 package rows20180616_227e11ab-4e07-4e34-b21d-ef965bae6272.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 98 of 114 · 2,266 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hygiene Clean Blueberry Lemonade Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCb5690e19-4f92-d667-e053-2995a90abd242023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Bubble Gum Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCb569875e-7a3d-17db-e053-2a95a90a3c2b2023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Mahogany Teakwood Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCb5696369-175a-8add-e053-2995a90a5be82023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Pumpkin Spice Hand Sanitizer Alcohol FreeBENZALKONIUM CHLORIDEUSA Broom LLCb2e8085d-8ab2-42c5-e053-2995a90aab372023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Luxury Clean Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCbda8fb1b-890e-b5c3-e053-2995a90a7b992023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Simple Hygiene Alcohol Free Foam Hand SanitizerBENZALKONIUM CHLORIDEFULLER INDUSTRIES, INCb6fdf78f-4b9b-aca7-e053-2995a90a991c2023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Lavender Blossom Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCbe34df37-d0ee-8d6a-e053-2a95a90aa2b52023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Leather Oak Hand Sanitizer Alcohol FreeBENZALKONIUM CHLORIDEUSA Broom LLCb2e77b4d-00b7-5c66-e053-2a95a90aa1742023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Vanilla Sugar Hand Sanitizer on the go and car safeBENZALKONIUM CHLORIDEUSA Broom LLCbbb44ec3-82ba-7053-e053-2995a90a69452023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Alcohol Free Hand SanitizerBENZALKONIUM CHLORIDEFULLER INDUSTRIES, INC0ebf85c5-21ee-4d14-b88f-d8c078791aef2023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Vanilla Woods Hand Sanitizer Car Safe Alcohol FreeBENZALKONIUM CHLORIDEUSA Broom LLCbafee8b1-2b06-48c0-e053-2a95a90a72242023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Spring Bloom Hand Sanitizer Bottle Alcohol FreeBENZALKONIUM CHLORIDEUSA Broom LLCba70f2b9-7a44-065c-e053-2a95a90a6eb22023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Clean Cotton Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCaffb0061-4347-7cd9-e053-2995a90ac1142023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Leather Oak Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCb5693dee-c75c-08b5-e053-2995a90a43902023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Clean Cotton Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCbda861a1-2e25-528c-e053-2a95a90a985e2023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Eucalyptus Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCb569b768-319b-89a0-e053-2a95a90af9012023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Balsam Fir Hand Sanitizer Alcohol FreeBENZALKONIUM CHLORIDEUSA Broom LLCb2e77184-b325-6673-e053-2995a90a7d792023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Unscented Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCaffc6874-b7c6-726b-e053-2995a90a8b0f2023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Spring Bloom Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCbe35349b-0f26-fa75-e053-2995a90a3b242023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Mahogany Teakwood Hand Sanitizer Alcohol FreeBENZALKONIUM CHLORIDEUSA Broom LLCb2e7d11b-c5bf-5c00-e053-2a95a90a4bbc2023-10-28WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.